Clinical effect of R610 for retinoic acid induced dermatitis.
- Conditions
- solar lentigo
- Registration Number
- JPRN-UMIN000003875
- Lead Sponsor
- Rohto Pharmaceutical Co., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
1. Subjects with rash, contact dermatitis, skin inflammation e.g. sunburn, and other skin abnormality. 2. Subjects with the following treatment history at baseline. 2.1 Treatment region 1)Topical preparations i)Within the past 12 weeks -Retinoic acid, adapalene ii)Within the past 2 weeks -Anti-inflammatory drugs (corticosteroid, nonsteroidal anti-inflammatory drug) 2)Other therapy i)Within the past 4 weeks -Chemical peelings, laser treatment, photo-therapy, plastic surgery treatment. 2.2 Systemic drugs, supplements i)Within the past 12 weeks -Retinoic acid ii)Within the past 4 weeks -Corticosteroid 3. Subjects with skin viral infection e.g. flat wart, herpes simplex. 4. Subjects who changed face cleanser or skin care products for the test regions within the past 2 weeks. 5. Subjects who exposed to the ultraviolet rays of the sun. 6. Subjects with systemic diseases, e.g. severe heart disease, renal disease, hepatic disease, respiratory disease, cardiovascular disease, and immune disease. 7. Subjects with atopic dermatitis or have a history of atopic dermatitis. 8. Subjects who had experience the contact dermatitis caused by the use of hydroquinone. 9. Females who are pregnant, trying to become pregnant (self-declared), during this study period, or breast feeding. 10. Participants of another clinical study within 4 months of study initiation. 11. Subjects who are improper as a participant in this study in judgement by the principal or other investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degrees of dermatitis (erythema, edema, crust, drying, desquamation, feeling of stimulation, burning sensation, itching, irritation)
- Secondary Outcome Measures
Name Time Method Efficacy -Skin symptom score -Hemoglobin index -Subject impression Other -Melanin index -Degree of skin tone color scale